Evaluation of a fecal pancreatic elastase-1 enzyme-linked immunosorbent assay: Assessment versus an established assay and implication in classifying pancreatic function

Clinica Chimica Acta; International Journal of Clinical Chemistry
J Alan EricksonEdward R Ashwood

Abstract

Disagreement continues regarding 2 fecal pancreatic elastase-1 (PE-1) ELISAs and their respective capabilities to assess pancreatic function. The BioServ Diagnostics polyclonal PE-1 ELISA was validated and its performance characteristics compared to the previously validated ScheBo Biotech monoclonal PE-1 ELISA. Split sample study results were analyzed by Deming regression and Bland-Altman plot analysis. Data mining was utilized to explore PE-1 distribution and evaluate PE-1 and fecal fat correlation. Analysis demonstrates limited quantitative agreement; slope=0.9640, intercept=10.787, R(2)=0.633. Means were 228.8 and 226.2 microg PE-1/g stool for the polyclonal and monoclonal assays respectively. Bland-Altman analysis showed 91% of paired values within 2 SD of their means. There was good qualitative agreement when interpreted against established intervals with 91% of results equivalent in pancreatic function classification. The remaining 9% varied by one classification level with no bias evident. The distribution of PE-1 concentrations (n=400, 0-25 years) classified 78% of subjects with normal pancreatic function, 7% with moderate pancreatic insufficiency and 15% with severe insufficiency. There was little agreement between PE-...Continue Reading

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Citations

Aug 9, 2013·Critical Care : the Official Journal of the Critical Care Forum·Sheng WangXiangyu Zhang
Feb 12, 2013·Pancreatology : Official Journal of the International Association of Pancreatology (IAP) ... [et Al.]·Luigi BeniniLuca Frulloni
May 13, 2010·Pancreatology : Official Journal of the International Association of Pancreatology (IAP) ... [et Al.]·Luca FrulloniItalo Vantini
Mar 3, 2010·Critical Care Nursing Clinics of North America·Mary Ann Jessee
Dec 19, 2012·The Journal of Pediatrics·Brian P O'SullivanDrucy Borowitz
Nov 25, 2011·Annals of Clinical Biochemistry·Ruth M Ayling
Apr 23, 2020·World Journal of Gastrointestinal Pathophysiology·Adithya M PathankiNikolaos A Chatzizacharias
Aug 4, 2020·Pediatrics International : Official Journal of the Japan Pediatric Society·Mitsuyoshi SuzukiToshiaki Shimizu
Jul 1, 2009·Current Opinion in Endocrinology, Diabetes, and Obesity

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